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  • 1.  Highlighting a Specific Ingredient in Cosmetic

    Posted 17-Sep-2015 10:29

    Dear All,

    On a cosmetic label, is it ok to highlight a particular ingredient including the percentage content on the principal display panel of the cosmetic? For example stating that a product contains 3% Dimethicone but not making a claim. I did not find any regulation that says you can or you can not.

    Regards,

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    Charles Jagun
    DURHAM NC
    United States
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  • 2.  RE: Highlighting a Specific Ingredient in Cosmetic

    Posted 18-Sep-2015 08:39

    Hi Charles.

    In 20+ years in this industry I have never seen FDA take action against a product making a callout of an ingredient on a cosmetic.  It happens routinely for some companies.  However, I will pose the following caveats to that point:

    1. Ensure that there is no implied drug claim on the product packaging.  For example, if 3% dimethicone is allowed under the Skin Protectant monograph as an approved active, making statement like "chapped skin", "relief of irritation" or "chapped lips" might get you caught up in a problem because these are all similar to claims allowed in the monograph and therefore could be seen to brand your product as a drug.

    2. Obviously, I really hope I don't need to say this but, your product actually needs to contain the ingredient at the level that you claim on your label.  I have seen some instances where labels became significant headaches for colleagues because the marketing team decided the product was too expensive or didn't "feel right" and issued a change order for the lab to lower the percentage of an ingredient and when the company was inspected the FDA found the discrepancy between the formula and the claim on the label and it became an issue.

    3. Remember your label is looked at in its totality.  So even if your label doesn't come outright and say something on the PDP, if it says it on another panel of the label it could still be used as evidence of your intended use so reviewing label language is obviously a significant exercise whenever you have a callout of a specific ingredient.

    So I guess my advice to you is to go through a thorough and complete review of the formula, the label and any and all claims (both explicit and implied) before you actually move forward with such a claim on pack.  And remember, graphics can also prove to be a "claim" that you need to consider when you review the labels!

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    Victor Mencarelli
    Sr. Manager - Regulatory Affairs
    Lake Success, NY, United States
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    Original Message


  • 3.  RE: Highlighting a Specific Ingredient in Cosmetic

    Posted 22-Sep-2015 12:09

    Thanks Victor.

    Useful information.


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    Charles Jagun
    DURHAM NC
    United States
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    Original Message


  • 4.  RE: Highlighting a Specific Ingredient in Cosmetic

    Posted 22-Sep-2015 12:41
    Charles,

    There have been a couple of FDA warning letters relating to "dimethicone."  You may refer to one of them at Warning Letter Associated with Dimethicone

    If a firm labels its cosmetic product with "3% Dimethicone," it is basically making a claim equivalent to an OTC skin protectant as dimethicone (1 to 20%) is considered as skin protectant APIs under 21 CFR 347.10.  

    Accordingly, it is reasonable to believe that the FDA can/will get excited about it.  
     
    s/ David
    ____________________________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR and GCS
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